Abstract 13768: Gender Differences in ICD-Related Complications in the PRAETORIAN Trial

Introduction: The PRAETORIAN trial has investigated the difference in complications between the subcutaneous implantable cardioverter-defibrillator (S-ICD) and the transvenous ICD (TV-ICD). Retrospective studies suggest that women experience more ICD-related complications, specifically related to the lead, than men. We aimed to evaluate this gender difference as a subanalysis of the PRAETORIAN trial. Methods: The PRAETORIAN trial (NCT01296022) is an international multicenter randomized trial. Patients with a class I or IIa ICD indication with no need for pacing therapy were randomized 1:1 to receive either an S-ICD or a TV-ICD and followed for a median of 49.1 months. ICD-related complications included all complications related to the lead or generator that led to medical or surgical intervention. Lead-related complications were defined as complications directly caused by insertion or chronic placement of the ICD lead, or leading to extraction, repositioning or replacement of the ICD lead. Results: A total of 849 patients were included, of whom 167 (19.7%) were female. ICD-related complications occurred in 6/89 women in the S-ICD group and 11/78 women in the TV-ICD group (HR 0.46, 95%CI 0.17-1.25). In men, 25/337 in the S-ICD group and 33/345 in the TV-ICD group had an ICD-related complication (HR 0.77, 95%CI 0.46-1.29). Kaplan Meier curves of both genders are shown in the figure. In Cox regression analysis, women had a higher risk of lead-related complications (HR 2.1, 95%CI 1.04-4.16, p = 0.04). Conclusions: Our prospective data show a more prominent trend in women to experience more ICD-related complications with the TV-ICD. This difference may be due to a significantly higher risk of lead-related complications in women. However, numbers are low and more research is needed to gain more insight into the gender-specific risks and benefits of ICD therapy.